BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELSPEEDY REPLACE RP 4X11.5MM

    MDR report key: 18917052 · Received March 15, 2024

    Report

    Report Number
    9611993-2024-053145
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    December 1, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K050406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION 15.03.2024 12:10:34 CET (5001035) IMPLANT FAILED DUE TO FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131007 NOBELSPEEDY REPLACE RP 4X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention